Forced Degradation Studies of Biopharmaceuticals

To fully characterise biological products, it is necessary to define the degradation pathways by which the product converts into non-active forms. This can be determined in real time with stability studies but these could take several years. This process can be accelerated by applying forced degradation conditions in terms of temperature, pH, redox, light, humidity and shear stress. The aim is to produce enough drug degradation products (5-30%) to be useful in stability indicating assay development and validation.

To predict how a molecule will behave in formal stability studies under ICH conditions

To provide a sensitive means of performing biosimilarity and comparability studies

Each drug will require a tailored forced degradation protocol to enable the optimum conditions to be utilised. This optimisation is performed using a robust feasibility study to identify optimal conditions resulting in suitable drug degradation levels.

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